FDA Review Panel · RA

FDA 510(k) Radiology Devices

FDA 510(k) Radiology Devices - Regulatory Overview

FDA 510(k) radiology devices include medical imaging systems and radiation therapy equipment. The FDA review panel code is RA.

Key modalities covered:

  • X-ray and fluoroscopy - digital radiography, fluoroscopy systems and C-arms
  • Computed tomography (CT) - whole-body and dedicated CT scanners
  • Magnetic resonance imaging (MRI) - 1.5T, 3T and extremity MRI systems
  • Ultrasound imaging - diagnostic, point-of-care and intravascular ultrasound
  • Radiation therapy - linear accelerators, brachytherapy and treatment planning
  • Nuclear medicine - PET, SPECT and gamma camera systems

15620
Total
15601
Cleared
148d
Avg (2y)
1976
Since
12803 Radiology devices
9126–9150 of 12803
Cleared Mar 16, 2000
BABY FACE
K994385 · Sonora Medical Systems
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 79d
Cleared Mar 14, 2000
BARCOMED 5MP1H
K000014 · Barco N.V.
LLZ · System, Image Processing, Radiological · 71d
Cleared Mar 14, 2000
BARCOMED 5MP2
K000016 · Barco N.V.
LLZ · System, Image Processing, Radiological · 71d
Cleared Mar 14, 2000
POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET
K000554 · Quantel Medical
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 25d
Cleared Mar 14, 2000
PROSTEC 125I BRACHYTHERAPY SEEDS
K993280 · Prostec, LLC
KXK · Source, Brachytherapy, Radionuclide · 166d
Cleared Mar 14, 2000
ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH
K994285 · Dentsply Intl.
EHD · Unit, X-ray, Extraoral With Timer · 85d
Cleared Mar 14, 2000
SURGI-VISION ESOPHAGEAL STYLET COIL
K994436 · Surgi-Vision, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 75d
Cleared Mar 09, 2000
BRACHYVISION 6.0
K992762 · Varian Assoc., Inc.
MUJ · System, Planning, Radiation Therapy Treatment · 205d
Cleared Mar 09, 2000
PEGASYS ULTRA
K993946 · Adac Laboratories
LLZ · System, Image Processing, Radiological · 111d
Cleared Mar 09, 2000
INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
K994270 · Visualization Technology, Inc.
LLZ · System, Image Processing, Radiological · 80d
Cleared Mar 07, 2000
CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)
K994167 · Ge Medical Systems F.I. Haifa
KPS · System, Tomography, Computed, Emission · 89d
Cleared Mar 07, 2000
AIRIS II
K994378 · Hitachi Medical Systems America, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 71d
Cleared Mar 02, 2000
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
K994282 · Medis Medical Imaging Systems BV
LNH · System, Nuclear Magnetic Resonance Imaging · 73d
Cleared Feb 24, 2000
7250 (MEGAS)
K994369 · Biosound Esaote, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 59d
Cleared Feb 23, 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K000002 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 51d
Cleared Feb 22, 2000
10 CURIE IRDIUM 192, CSN00100-192
K991571 · Alpha-Omega Services, Inc.
KXK · Source, Brachytherapy, Radionuclide · 293d
Cleared Feb 22, 2000
REMOTEIMAGE SYSTEM
K994228 · Etrauma.Com Corp.
LLZ · System, Image Processing, Radiological · 69d
Cleared Feb 16, 2000
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
K000159 · Agfa Corp.
IXK · System, Imaging, X-ray, Electrostatic · 28d
Cleared Feb 16, 2000
SOMAVISION
K992751 · Varian Assoc., Inc.
KPQ · System, Simulation, Radiation Therapy · 184d
Cleared Feb 15, 2000
LIGHTSPEED 2.0CT SCANNER SYSTEM
K000300 · Ge Medical Systems, Inc.
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Feb 14, 2000
LCV+ VERSION 2
K993037 · Ge Medical Systems, Inc.
OWB · Interventional Fluoroscopic X-ray System · 158d
Cleared Feb 14, 2000
IDX-60 INTRAORAL X-RAY
K993958 · X-Cel X-Ray Corp.
MUH · System, X-ray, Extraoral Source, Digital · 84d
Cleared Feb 14, 2000
ISOCENTRIC BEAM CHECKER
K993959 · Mick Radio-Nuclear Instruments, Inc.
IYE · Accelerator, Linear, Medical · 84d
Cleared Feb 14, 2000
PERMA-DOC PHANTOM
K993960 · Mick Radio-Nuclear Instruments, Inc.
IYE · Accelerator, Linear, Medical · 84d
Cleared Feb 14, 2000
ISSA PHAROS
K994054 · Vams Tec, D.O.O.
LLZ · System, Image Processing, Radiological · 76d

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All categories 12803 LLZ System, Image Processing, Radiological 2033 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1127 LNH System, Nuclear Magnetic Resonance Imaging 997 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 685 IYE Accelerator, Linear, Medical 585 MOS Coil, Magnetic Resonance, Specialty 456 MQB Solid State X-ray Imager (flat Panel/digital Imager) 411 KPS System, Tomography, Computed, Emission 387 ITX Transducer, Ultrasonic, Diagnostic 347 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 313 KPR System, X-ray, Stationary 294 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 192